Analysis of prognostic factors in newly diagnosed patients with acute promyelocytic leukemia: the APL92 study of the Japan Adult Leukemia Study Group (JALSG) (original) (raw)

Abstract.

All-_trans_-retinoic acid (ATRA) has been incorporated in front-line therapy for newly diagnosed acute promyelocytic leukemia (APL). We conducted a multicenter study of differentiation therapy with ATRA alone or in combination with chemotherapy followed by intensive postremission chemotherapy in patients with APL (the JALSG APL92 study), and analyzed prognostic factors to increase the cure rate in our subsequent trial. From 1992 to 1997, adult patients with newly diagnosed APL received oral ATRA 45 mg/m2 daily alone until complete remission (CR) if initial leukocyte counts were <3.0×109/l, and ATRA daily plus daunorubicin (DNR) 40 mg/m2×3 days plus enocitabine (BHAC) 200 mg/m2×5 days if leukocyte counts were ≥3.0×109/l. If peripheral blasts exceeded 1.0×109/l during therapy, DNR×3 days plus BHAC×5 days was added. After CR was achieved, three courses of consolidation and six courses of maintenance/intensification chemotherapy were administered. Of 376 patients enrolled, 369 were evaluable (median age 46 years, range 15–86 years; median leukocyte counts 2.0×109/l), and 333 (90%) achieved CR (94% of patients treated with ATRA alone, 88% with ATRA plus later chemotherapy, 89% with ATRA plus initial chemotherapy, and 86% with ATRA plus initial and later chemotherapy). At a median follow-up of 45 months, the predicted 6-year overall and event-free survival (EFS) rates for all patients were 65% and 52%, respectively. Favorable prognostic factors for CR were younger age, no or mild purpura, high serum total protein level, low lactate dehydrogenase level, and no or mild disseminated intravascular coagulation (DIC). Favorable prognostic factors for EFS were leukocyte counts <10.0×109/l, mild DIC, and no sepsis during induction therapy. In the JALSG APL97 study, we intensified chemotherapy for patients with leukocyte counts ≥3.0×109/l, and are randomly testing whether further chemotherapy is required for APL patients with negative PCR for PML/retinoic acid receptor α in the maintenance phase.

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Authors and Affiliations

  1. Second Department of Internal Medicine, Kumamoto University School of Medicine, 1-1-1 Honjo, Kumamoto 860-8556, Japan, , , , ,
    Norio Asou
  2. First Department of Internal Medicine, Nagoya University School of Medicine, Nagoya, Japan, , , , ,
    Koichi Adachi
  3. Third Department of Internal Medicine, Gunma University School of Medicine, Maebashi, Japan, , , , ,
    Jun-ichi Tamura
  4. Second Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan, , , , ,
    Akihisa Kanamaru
  5. Second Department of Internal Medicine, Mie University School of Medicine, Tsu, Japan, , , , ,
    Shin-ichi Kageyama
  6. Fifth Department of Internal Medicine, Center for Adult Diseases, Osaka, Japan, , , , ,
    Akira Hiraoka
  7. Second Department of Internal Medicine, Okayama University School of Medicine, Okayama, Japan, , , , ,
    Eijiro Omoto
  8. Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan, , , , ,
    Hideki Akiyama
  9. Third Department of Internal Medicine, Kinki University School of Medicine, Osaka, Japan, , , , ,
    Kazuo Tsubaki
  10. Third Department of Internal Medicine, Dokkyo University School of Medicine, Tochigi, Japan, , , , ,
    Kenji Saito
  11. Department of Hematology, Atomic Disease Institute, Nagasaki University School of Medicine, Nagasaki, Japan, , , , ,
    Kazutaka Kuriyama
  12. Second Department of Internal Medicine, Chiba University Hospital, Chiba, Japan, , , , ,
    Hakumei Oh
  13. Second Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan, , , , ,
    Kiyoshi Kitano
  14. Department of Internal Medicine, Saiseikai Maebashi Hospital, Maebashi, Japan, , , , ,
    Shuichi Miyawaki
  15. Department of Internal Medicine, National Cancer Center Central Hospital, Tokyo, Japan, , , , ,
    Kunihiko Takeyama
  16. Division of Hematology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan, , , , ,
    Osamu Yamada
  17. Second Department of Internal Medicine, Nara Medical University, Kashihara, Japan, , , , ,
    Kiyoshi Nishikawa
  18. First Department of Internal Medicine, St. Marianna University Hospital, Kawasaki, Japan, , , , ,
    Masatomo Takahashi
  19. Center for Hematological Disorders, Ohta Nishinouchi Hospital, Kooriyama, Japan, , , , ,
    Shin Matsuda
  20. Third Department of Internal Medicine, Kanazawa University School of Medicine, Kanazawa, Japan, , , , ,
    Shigeki Ohtake
  21. Aichi Cancer Center Hospital, Nagoya, Japan, , , , ,
    Ryuzo Ohno

Authors

  1. Norio Asou
  2. Koichi Adachi
  3. Jun-ichi Tamura
  4. Akihisa Kanamaru
  5. Shin-ichi Kageyama
  6. Akira Hiraoka
  7. Eijiro Omoto
  8. Hideki Akiyama
  9. Kazuo Tsubaki
  10. Kenji Saito
  11. Kazutaka Kuriyama
  12. Hakumei Oh
  13. Kiyoshi Kitano
  14. Shuichi Miyawaki
  15. Kunihiko Takeyama
  16. Osamu Yamada
  17. Kiyoshi Nishikawa
  18. Masatomo Takahashi
  19. Shin Matsuda
  20. Shigeki Ohtake
  21. Ryuzo Ohno

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Asou, N., Adachi, K., Tamura, Ji. et al. Analysis of prognostic factors in newly diagnosed patients with acute promyelocytic leukemia: the APL92 study of the Japan Adult Leukemia Study Group (JALSG).Cancer Chemother Pharmacol 48 (Suppl 1), S65–S71 (2001). https://doi.org/10.1007/s002800100308

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